Study of VOY-101 in Patients With Advanced Non-Neovascular Age-Related Macular Degeneration

Age-related Macular Degeneration Clinical Trial

Official title:

Phase 1/2a Dose Escalation Study of VOY-101 in Patients With Advanced Non-Neovascular Age-Related Macular Degeneration

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05380492
• Other study ID #: PBI-AMD-001
• Status: Active, not recruiting
• Phase: Phase 1/Phase 2
• Start date: November 17, 2022
• Est. completion date: November 2025

Study information

• Verified date: April 2024
• Source: Perceive Biotherapeutics, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This safety study comprises a dose escalation study of VOY-101, followed by a cohort of subjects randomized to the maximum tolerated dose arm, a lower dose arm, and control arm.

Description:

This is a prospective, multi-center safety phase 1/2a study to evaluate the safety of a single, unilateral intravitreal (IVT) injection of three dose levels of VOY-101 therapy in subjects with late-stage non-neovascular age-related macular degeneration (AMD).

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 45
• Est. completion date: November 2025
• Est. primary completion date: November 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 50 Years and older

Eligibility

Inclusion Criteria:

1. Are =50 years of age at the time of consent.

2. Are willing and able to understand and provide written informed consent.

3. Are willing and able to return for scheduled treatment and follow-up examinations.

4. Are able to undergo ETDRS BCDVA testing and ophthalmic imaging.

5. Well-demarcated GA secondary to AMD in the absence of MNV and in the absence of history of MNV.

6. Absence of signs of non-exudative MNV.

7. Additional Ocular Inclusion Criteria

8. Meet certain genotype criteria for risk of AMD.

Exclusion Criteria:

1. Are women of childbearing potential (WOCBP) and are pregnant or unwilling to use and document use of effective contraception for the duration of the study.

2. Additional Systemic, Ocular, and Genetic Exclusion Criteria.

Related Conditions & MeSH terms

• Age-related Macular Degeneration
• Geographic Atrophy
• Macular Degeneration

Intervention

Biological:
• VOY-101
Intravitreal injection of VOY-101

Locations

Country	Name	City	State
United States	Retina Consultants of Texas	Bellaire	Texas
United States	Ophthalmic Consultants of Boston	Boston	Massachusetts
United States	University of Utah	Salt Lake City	Utah

Sponsors (1)

Lead Sponsor	Collaborator
Perceive Biotherapeutics, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Safety Endpoints	1. Frequency of ocular and systemic adverse events (AEs) (serious [SAEs] and treatment-emergent non-serious adverse events [TEAEs])	Through 24 months